—#49692

Product

Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component, Fenestrated Sterile Made in Ireland

FDA product code: KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Hip Fracture Stem # 1; Catalog Number 6942-0-010; Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204, 6660205, 7237401, 7237402, 7237403, 7237404, 7237405, 7934101, 7934102, 7934103, 7934104, 7934105, 8345801, 8345802, 8345803, 8345804, 9714001, 9911901, 9911902, 10420701, 10420702, 10756001, 11319201, 11369101, 11369102, 11369103, 11605201, 11605202, 13093201, 13093301, 13093302,13093401, 13093501, 13562501, 13562502, 13782001, 15550502, 16060001, 16060002, 16840301, 17289301, 17289302, 18448101, 18448102, 18448103, 18593901, 14413201R, P4FEA.

Why it was recalled

Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

Root cause (FDA determination)

Other

Action the firm took

Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2006-11-28
Posted by FDA: 2007-01-13
Terminated: 2007-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49692. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.